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28 days old

Quality Assurance Analyst

Kelly Services
San Diego, CA 92108
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary position with a client that is seeking a **Quality Assurance Analyst in San Diego, CA. If interested/available, please reach out to Bryan Heffley directly at bryh262@kellyservices.com.**


PAY: $$30-$35/hr W2


DURATION: Contract length through 1/9/23


LOCATION: On-site San Diego, CA


SCHEDULE: Mon Fri (1st shift)


**SUMMARY OF POSITION:**


Under minimal supervision, this role carries out the complex daily operations related to of the non-conformance function in Quality Assurance. This role assists departments through the non-conformance and CAPA processes using established procedures.


**ESSENTIAL FUNCTIONS:**


+ Manage complex Non-Conformance and Corrective Action/Preventive Action (CAPA) reports

+ Ensure completeness of the non-conformance and CAPA files

+ Assist internal customers with preparation of complex non-conformance and CAPA forms

+ Utilize JDE to perform transactions and verify product information

+ Prepare metrics for weekly trending report and monthly management review meetings

+ Develop and issue Trend Codes for complex non-conformances

+ Assign, review and conduct complex investigations regarding non-conformance trends

+ Assist in training junior personnel

+ Provide support for internal and external audits

+ Carries out duties in compliance with established business policies

+ Perform other duties & projects as assigned


**INTERACTIONS:**


Frequently interacts with peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others. Internal Customers Directly interacting, by such activities as non-conformance and CAPA forms creation or revision, with internal customers and corporate partners on Quality Systems compliance and support. Respond to issues and concerns on the product and proper non-conformance report process. External Customer - Directly interacting, by such activities as certificate creation or revision, with external customers and regulatory agencies. Quality Team and other Department Personnel Supports non-conformance personnel in achieving objectives in support of the vision and mission of the corporation and department.


**WORK ENVIRONMENT:**


The work environment characteristics are representative of both an office and manufacturing environment, which may include working in varying temperature environments. Flexible work hours to meet project deadlines.


**PHYSICAL DEMANDS:**


+ Position requires ability to lift 30 lbs. on a regular basis.

+ Typically spends 20% of time in meetings; 80% of time at the desk on computer/doing paperwork/ on phone, doing analytical work.

+ Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus.

+ Must be able to visually review products and ensure compliance to applicable/established Quality Standards.

+ Position will require use of Personal Protective Equipment as posted


**EDUCATION, SKILLS & EXPERIENCE:**


+ BS/BA degree or equivalent in related field required


+ Three to five years of related experience required, in a high-volume manufacturing environment


+ Working knowledge of Quality Assurance in a medical device manufacturing environment required preferably in-vitro diagnostic

+ Knowledge of Quality System Regulations required

+ Advanced skills in MS Office required, and Master Control and JDE preferred

+ Must be detail-orientated, self-motivated, and available for flexible scheduling

+ Strong verbal and written communication, problem solving and detail oriented

+ Carrying out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision

+ Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment

+ Demonstrates commitment to the development, implementation, and effectiveness the Quality Management System per ISO, FDA, and other regulatory agencies

+ Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-27 Expires: 2022-06-27

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Quality Assurance Analyst

Kelly Services
San Diego, CA 92108

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